Abstract: SA-OR079
Clinical Trial Assessing the Safety and Efficacy of Human Bone Marrow-Derived Allogeneic Mesenchymal Stem Cell Therapy for Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients
Session Information
- Transplantation: Clinical Controversies in Donation, Access, Monitoring, and Treatment
November 08, 2025 | Location: Room 370A, Convention Center
Abstract Time: 05:30 PM - 05:40 PM
Category: Transplantation
- 2102 Transplantation: Clinical
Authors
- Park, Hyeran, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea (the Republic of)
- Lee, Hanbi, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea (the Republic of)
- Yoon, Hye Eun, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea (the Republic of)
- Chung, Byung ha, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea (the Republic of)
- Kim, Hyung Duk, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea (the Republic of)
Background
Chronic active antibody-mediated rejection (cABMR) remains a significant challenge in Kidney Transplant Recipients (KTR), with limited effective therapies. This study evaluated the safety and efficacy of allogenic human bone marrow-derived mesenchymal stem cell (hBM-MSC) therapy in KTR with cABMR.
Methods
Seven cABMR patients received four infusions of hBM-MSC (1×10^6 cells/kg), one every other week. The primary outcome was clinical safety, focusing on short-term adverse events. Secondary outcomes included changes in allograft function, mean fluorescence intensity (MFI) of donor-specific anti-human leukocyte antigen antibodies (HLA-DSA), allogenic immune response as determined by Elispot assay, lymphocyte subset analysis, infection-free survival, and graft survival compared to 18 historical rituximab/IVIg (RTX/IVIg) group using propensity score matching.
Results
Patients who received hBM-MSC therapy were, on average, 9.3 ± 8.7 years post-transplantation. Six patients completed treatment, and one patient received two doses. No immediate side effects were observed. One patient developed Pneumocystis jirovecii pneumonia (PJP) three weeks after treatment and died six weeks post-treatment. Among those who completed therapy, the eGFR slope shifted from –Δ16.6% to –Δ2.4% over the 6 month periods before and after treatment, suggesting a stabilization of eGFR decline, proteinuria decreased, and MFI of HLA-DSA declined. T-cell subset analysis showed increased CD8+CD45RA+CCR7- T cells and CD4+CD25+CD127low T cells with decreased CD8+CCR7+CD45RO+/CD45RA+ T cells. Kaplan–Meier analysis demonstrated no significant difference in infection-free survival or death-censored graft survival compared to those of the propensity score-matched RTX/IVIg control group.
Conclusion
hBM-MSC therapy was generally well tolerated for KTR with cABMR and demonstrated favorable immunomodulatory effects. Larger, controlled trials with extended period are required to validate these findings and better define the role of hBM-MSC therapy for cABMR.
Funding
- Government Support – Non-U.S.